CARD System for Vaccination Pain

Overseen By Victoria Gudzak, MSc

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Toronto

Disqualifiers: Non-English speakers

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the CARD (Comfort Ask Relax Distract) method to make vaccinations less stressful and more comfortable for individuals receiving their shots at community pharmacies. It compares two groups: one that has used CARD before and another using it for the first time. CARD includes elements like education and creating a relaxing environment to improve the vaccination experience. Individuals getting vaccinated at a participating Wholehealth Pharmacy might be a good fit for this study. As an unphased trial, this study offers a unique opportunity to enhance the vaccination experience while contributing to valuable research.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the CARD System is safe for vaccination delivery?

Research has shown that the CARD system, which stands for Comfort Ask Relax Distract, safely helps people feel more at ease during vaccinations. This system uses simple methods to reduce stress when receiving a shot. Studies have found that it helps people cope better by employing techniques like relaxation and distraction.

No reports of negative side effects have emerged from using the CARD system itself. It aims to make the vaccination process smoother and less stressful without altering the vaccine in any way. Therefore, it is considered safe and well-tolerated for use in community pharmacies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CARD system because it offers a novel approach to reducing vaccination pain that goes beyond traditional methods like topical anesthetics or distraction techniques. CARD focuses on creating a more comfortable vaccination experience through its comprehensive framework, which includes education, environment, engagement, and evaluation components. This method aims to address the psychological and environmental factors affecting pain perception, potentially leading to a less stressful experience for patients. By implementing CARD in pharmacies, researchers hope to make vaccinations less intimidating and more accessible, especially during the busy fall/winter vaccination seasons.

What evidence suggests that the CARD System is effective for reducing vaccination pain?

Research has shown that the CARD (Comfort Ask Relax Distract) system reduces stress during vaccination by alleviating fear, pain, and dizziness. In this trial, participants will experience either the "Sustained CARD" or "First-time CARD" approach. Studies have found that people report a better experience with CARD compared to past vaccinations. The system also reduces the likelihood of fainting and other stress-related reactions after the shot. Additionally, CARD has increased vaccination rates. This approach involves providing information and creating a calm setting, helping people feel more at ease during vaccination. ^{1 2 3 4 6}

Who Is on the Research Team?

Anna Taddio, PhD

Principal Investigator

Leslie Dan Faculty Of Pharmacy, University Of Toronto

Are You a Good Fit for This Trial?

This trial is for individuals receiving vaccinations at community pharmacies partnered with Wholehealth Pharmacy Partners. It's specifically designed to assess the CARD system, which aims to reduce vaccination pain and anxiety.

Inclusion Criteria

Clients undergoing vaccination in participating pharmacies

Providers working in participating pharmacies

Exclusion Criteria

Unable to speak and write in English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Pharmacies implement the CARD system for vaccination delivery during the 2024-2025 fall/winter season

6 months

Ongoing visits as needed for vaccinations

Data Collection

Feedback collected from vaccine clients using a paper survey tracking experiences and symptoms during vaccination

6 months

Follow-up

Participants are monitored for implementation outcomes and feedback is collected from providers

3 months

What Are the Treatments Tested in This Trial?

Interventions

• CARD (Comfort Ask Relax System)

Trial Overview The study tests the 'Comfort Ask Relax Distract' (CARD) system during vaccine administration in two groups: those who used CARD previously and those new to it, comparing its effectiveness in reducing discomfort.

How Is the Trial Designed?

Group I: Sustained CARD Experimental Treatment 1 Intervention

CARD is being used for the 2nd year in a row as the vaccination delivery framework in participating pharmacies (It was used in the 2023-2024 fall/winter vaccination season and is now being sustained in the 2024-2025 fall/winter season). CARD comprises of education, environment, engagement and evaluation components.

Group II: First-time CARD Active Control 1 Intervention

CARD is being used for the 1st time as the vaccination delivery framework in participating pharmacies (2024-2025 fall/winter vaccinations only). CARD comprises of education, environment, engagement and evaluation components.

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+

Wholehealth Pharmacy Partners

Collaborator

Trials

2

Recruited

2,500+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12087484/

CARD (Comfort Ask Relax Distract) and community ... The CARD system (Comfort Ask Relax Distract) is a protocol for vaccine delivery that includes interventions that facilitate vaccine recipient coping.

2. tandfonline.com tandfonline.com/doi/full/10.1080/21645515.2025.2488064

Full article: CARD (Comfort Ask Relax Distract) and ... This paper reports on the effectiveness outcomes of the trial. Vaccine recipients rated their vaccination experience compared to their last vaccination (primary ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X22002249

Impact of the CARD (Comfort Ask Relax Distract) system on ... Outcomes included stress-related symptoms (fear – primary outcome, pain, dizziness, fainting, post-vaccination reactions), use of coping ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12330231/

Effect of CARD (Comfort-Ask-Relax-Distract) on ... This study demonstrates effectiveness of CARD for increasing vaccination uptake. Evaluation of impact in other geographical regions is warranted ...

5. journals.lww.com journals.lww.com/pain/fulltext/2024/03000/card__comfort_ask_relax_distract__for_school_based.16.aspx

CARD (Comfort Ask Relax Distract) for school-based... : PAIN Other effectiveness outcomes included nurse-reported episodes of fainting (yes/no) and postimmunization stress-related responses experienced after students ...

6. canada.ca canada.ca/en/public-health/services/immunization-vaccines/vaccination-webinars-webcasts-health-professionals/implementing-card-system-vaccination-practice.html

ask-relax-distract) system to support vaccination in practice ... We use the CARD System: comfort, ask, relax, and distract. We provide handouts with a checklist of accommodations we are able to support.